Irrigation line, Bien Air

GUDID 08056646504930

Tube set sterile S600 (10/pkg)

OMNIA SRL

Disposable surgical irrigation/aspiration system

• Primary Device ID: 08056646504930
• NIH Device Record Key: 354ad956-fe91-48ad-b892-6e4c9aafc62d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrigation line, Bien Air
• Version Model Number: 32.F0241.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646504930 [Unit of Use]
GS1	08056646504947 [Primary]

FDA Product Code

• EFS: Unit, Oral Irrigation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-17
• Device Publish Date: 2021-08-09

Devices Manufactured by OMNIA SRL

• 08056646500017 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 3/0 - 19 mm 3/8 Needle - Body Reverse Cutting
• 08056646500031 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 4/0 - 16 mm 3/8 Needle - Body Reverse Cutting
• 08056646500055 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 - 12 mm 1/2 Needle - Body Reverse Cutting
• 08056646500079 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 6/0 - 11 mm 1/2 Needle - Body Reverse Cutting
• 08056646500086 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 -12 mm Needle 3/8 - Body Reverse Cutting
• 08056646500116 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
• 08056646500123 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 4/0 - Diamond tip 18 mm Needle 3/8 - Round Body
• 08056646500154 - Sterile PTFE Surgical Suture: 2025-04-22 PTFE Suture 75 cm - 5/0 - Diamond tip 18 mm Needle 3/8 - Round Body